TOPIC: CSV– CSA – GAMP – DI (Computer System Validation, Comp Soft Assurance, Good Automated Manufacturing Practices, Data Integrity)
First, a reminder about FDA Guidance Documents: FDA guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
On September 13, 2022, the FDA issued the CSA draft guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. The draft guidance is intended to: (1) Describe “computer software assurance” as a risk-based approach to establish confidence in the automation used for production or quality systems, and identify where additional rigor may be appropriate; and (2) Describe various methods and testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfill regulatory requirements, such as computer software validation requirements in 21 CFR part 820.
The draft aims to formalize and document the new world order of computerized system assurance, or CSA. MEDVACON can assist you and your company with understanding how your existing Computer System Validation methodology can be modified to implement the critical thinking introduced in the FDA CSA Guidance and most current GAMP5.
When it is final, the CSA Draft guidance will supplement (NOT REPLACE) FDA’s guidance, “General Principles of Software Validation” (“Software Validation guidance”), HOWEVER the CSA guidance will supersede Section 6 (“Validation of Automated Process Equipment and Quality System Software”) of the Software Validation guidance.
While the Draft CSA guidance makes many references to 21 CFR 820 as well as medical device manufacturing, it is important to note that this guidance is also intended to be applicable to Pharmaceutical, Biopharmaceutic, and any life sciences manufacturing Quality System. Medvacon’s experts can assist you and your team with identifying the references in the predicate rules making CSA universally applicable to all life science companies.
Compliance with the Quality System regulation, Part 820, is required for manufacturers of finished medical devices to the extent they engage in operations to which Part 820 applies. The Quality System regulation includes requirements for medical device manufacturers to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications (21 CFR 820.70, Production and Process Controls), including requirements for manufacturers to validate computer software used as part of production or the quality system for its intended use (see 21 CFR 820.70(i)).4 Recommending best practices should promote product quality and patient safety, and correlate to higher-quality outcomes. The CSA draft guidance addresses practices relating to computers and automated data processing systems used as part of production or the quality system.
Regarding the scope of CSA: When final, the CSA guidance is intended to provide recommendations regarding computer software assurance for computers or automated data processing systems used as part of production or the quality system. It is not intended to provide a complete description of all software validation principles. The FDA has previously outlined principles for software validation, including managing changes as part of the software lifecycle, in FDA’s Software Validation guidance. The CSA guidance applies the risk-based approach to software validation discussed in the Software Validation guidance to production or quality system software. This guidance additionally discusses specific risk considerations, acceptable testing methods, and efficient generation of objective evidence for production or quality system software.
